CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 736 enrolled
Drug / intervention
Docetaxel +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00333775
NCT00333775Phase 3Completed
CompareCT.gov

A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

Hoffmann-La Roche·interventional·Posted Jun 6, 2006·Updated Jan 27, 2016

In Brief

A Phase 3 clinical trial evaluating Docetaxel, Placebo to bevacizumab, and 1 other intervention for Breast Cancer. Completed, enrolled 736 participants across 114 sites in 24 countries.

Detailed Summary

This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Austria, Belgium, Brazil, Canada, China, France, Germany, Italy, Lithuania, Mexico, Netherlands, Panama, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2006
Enrollment StartMar 1, 2006
Primary CompletionOct 1, 2007
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.1 years ago

Interventions

Docetaxeldrug

Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

Placebo to bevacizumabdrug

Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Bevacizumabdrug

Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.